Testing a new pancreatic enzyme replacement therapy for cystic fibrosis

Plain-English translation of NCT07450547 on ClinicalTrials.gov ↗ · Source last updated May 2026 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing a new pancreatic enzyme replacement therapy called ANG003 for people with cystic fibrosis who have exocrine pancreatic insufficiency — a condition where the pancreas doesn't produce enough digestive enzymes. Researchers want to see whether this medication works as well as , the current standard enzyme replacement, and whether it is safe to use. You would be randomly assigned to take one of two different doses of the medication, continue with , or temporarily stop taking enzymes while being monitored.

People with cystic fibrosis often need enzyme replacement therapy to help digest food, but current options like may not work equally well for everyone. This trial is looking for new treatment options that might be more effective or better tolerated by patients.

Do you qualify?

You likely qualify if…

you are at least 12 years old (or 18 years old if you are in the European Union)
you have been diagnosed with cystic fibrosis
you have severe pancreatic insufficiency confirmed by a fecal elastase test
you have been taking a stable dose of pancreatic enzymes for at least 90 days before joining
you have a healthy body weight for your age

You likely don't qualify if…

you have a history of fibrosing colonopathy or bowel obstruction in the past 6 months
you have had a lung or liver transplant, or major bowel surgery in the past 6 months
you are allergic or have had severe reactions to pancreatic enzymes, Creon, or certain food dyes
you have a chronic diarrheal condition unrelated to your pancreatic insufficiency, or severe constipation
you are currently using a feeding tube or have had a Clostridioides difficile infection in the past 6 months

What participation looks like

You would first spend 14 days taking to establish a baseline, then have a stool test to measure how well your pancreas is working. If you qualify, you would be randomly assigned to one of four groups: two groups would take different doses of ANG003, one group would continue , or one group would temporarily stop taking enzymes. You would then take your assigned treatment for 21 days and have another stool test to see how well it worked. The study involves multiple clinic visits and stool samples.

AI-generated summary from trial data · Jun 3, 2026 · Not medical advice

Trial locations(26 sites)

United States

Long Beach Memorial Medical Center, Long Beach, California

Center for Cystic Fibrosis at Keck Medical Center of USC, Los Angeles, California

National Jewish Health, Denver, Colorado

University of Florida, Gainesville, Florida

Central Florida Pulmonary Group, Orlando, Florida